• eCOA Library Manager, Digital Health R&D

  NOTE : 2 year Fixed Term Contract - Possibility or Perm role at the end of this duration.

  Join AstraZeneca and help us deliver life changing medicines by supporting our advancements in digital R&D.

  At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

  Overview of Business Unit

  Digital Health R&D’s ambition is to transform healthcare, powered by digital, science and partnerships, to deliver the healthcare outcomes and experience that patients care about the most. Now we are further accelerating our transformation efforts to ensure we demonstrate the best in new technology and leading-edge capabilities to keep us at the forefront of future drug development.

  Digital Health R&D is reimagining how we work to position AstraZeneca as an industry leader, making the development & delivery of new medicines easier. We’re doing this by harnessing the latest innovations enabled by digital, data & analytics and working with our people to design and build the technology and working practices.

  AstraZeneca’s Digital Health R&D Patient Health & Innovation organisation develops digital solutions to support our development and commercial drug portfolios. These digital solutions (e.g. Unify) encompass connected monitoring devices and sensors coupled with medical device software to:

  • Improve clinical development, through optimising data collection and improving communications between AZ, HCP and patients
  • Provide enriched data sets to support regulatory submissions, and differentiated labelling
  • Optimise real world medication use by patients and deliver digital interventions to improve clinical outcomes

  As part of the Digital Health R&D the team will develop and execute AZ’s R&D Digital strategy. The program has already delivered the first versions of bespoke digital solutions for clinical trials globally, built on a standardized set of modules to enable identification and recruitment of patients, ongoing engagement and retention, support to sites and collection of data directly from patients.

  What you will do

  The eCOA Library Manager will lead our work in establishing a state-of-the-art flexible library for delivery of eCOA in all types of clinical trials together with the Unify Deployment team, Development Operations and other parts of AstraZeneca. The role will work with other eCOA SMEs within and outside AstraZeneca to deliver an innovative approach to efficiently manage and uphold a library of relevant eCOA instruments to allow them to be readily deployed into clinical trials. You will work in a team of Product Managers/Owners and Digital Patient Solution experts to jointly deliver a flexible product that covers most aspects of patient interactions in a clinical trial and deploy a high quality eCOA solution.

  Additionally, you will provide organizational support and product delivery fulfilment as it relates to translations implementation and copyrighted instrument licensing for the eCOA Library. This role includes providing ownership, oversight, and maintenance of the creation of a standard component library.

  
  
  Typical Accountabilities

  • Responsible for development, oversight and support of standard library components and deployment.
  • Responsible for translations implementation of products and associated materials, linguistic validation, instrument licensing procurement, and general instrument support across eCOA
  • Initiate and enforce continuous improvement initiatives geared to improve translation quality, process efficiency, harmonization across products, and reduce cost through tool and process enhancements that are scalable to various volume requirements.
  • Provide organizational support as it relates to management of instrument sub-licensing.
  • Primary contact to manage client and vendor escalations related to translations and instrument support.
  • Ensure all practices and procedures meet the regulatory compliance standards for Good Clinical Practices.

  Essential Requirements

  • BS/BA
  • Experience in Copyright Law and/or IP strongly preferred.
  • Ability to negotiate with study teams and copyright holders.
  • Excellent leadership and team skills.
  • Strong Communication skills - verbal, written, and presentation skills required.
  • Knowledge of 21 CFR Part 11 required.
  • Strong proofreading and attention to detail is required.
  • Excellent communication organization skills.
  • Excellent analytical, problem solving, and Root Cause Analysis skills.
  • Must be able to drive for results in a fast-paced environment.

  Why AstraZeneca?

  At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

  So, what’s next!

  Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

  Where can I find out more?

  Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

  Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

  Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

  Competitive Salary and Benefits

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.